Using Magnetic Resonance Imaging to Evaluate Heart Vessel Function After Angioplasty or Stent Placement Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00692991
Recruitment Status : Completed
First Posted : June 6, 2008
Last Update Posted : February 23, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Katherine C. Wu, Johns Hopkins University

Brief Summary:
Coronary artery disease (CAD) is caused by a narrowing of the blood vessels that supply blood and oxygen to the heart. Balloon angioplasty and stent placement are two treatment options for people with reduced heart function caused by CAD. This study will use magnetic resonance imaging (MRI) procedures to evaluate heart function over time in people with CAD who have undergone a balloon angioplasty or stent placement procedure.

Condition or disease
Myocardial Infarction Angina, Unstable Cardiomyopathy, Hypertrophic

Detailed Description:

CAD is the most common type of heart disease in the United States. It occurs when the arteries that supply blood to the heart become hardened and narrowed because of a build-up of cholesterol and plaque on the inner walls of the arteries. Over time, less blood is able to flow through the arteries, depriving the heart of the blood and oxygen it needs. If left untreated, CAD can lead to heart failure, heart attack, and arrhythmias. Someone with plaque build-up may undergo a percutaneous coronary intervention (PCI) to unblock the narrowed arteries and increase blood flow. PCI encompasses a variety of procedures, including balloon angioplasty and stent placement. In balloon angioplasty, a small balloon is inserted into the heart artery and then inflated. This pushes the plaque against the artery walls and widens the artery. Stents are wire mesh tubes that are permanently implanted in the artery to keep it propped open. Although balloon angioplasty and stent placement procedures open up blockages in the large vessels of the heart, the tiny vessels of the heart may become blocked after these procedures, which may affect how the heart heals. This study will use MRI to examine heart function in people who have undergone PCI procedures. Study researchers will attempt to define how often blockages of the tiny vessels occur after PCI procedures, the factors that lead to the blockages, and how often blockages affect healing of the heart.

This study will enroll people who are undergoing a PCI procedure. Participants will undergo an MRI scan of the heart before and after the PCI procedure. During the 72 hours after the procedure, electrocardiogram (EKG) will be used to monitor heart electrical activity. At a study visit 10 days after the PCI procedure and at a follow-up visit 6 to 12 months later, participants will undergo an MRI, EKG, and blood collection. Study staff will call participants every 6 months for 5 years to collect medical information.

Study Type : Observational
Actual Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microvascular Obstruction by Contrast-enhanced MRI Following Percutaneous Coronary Interventions
Study Start Date : October 1999
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

People undergoing percutaneous coronary interventions.

Primary Outcome Measures :
  1. Prevalence of microvascular obstruction by MRI in participants who may or may not have had an acute heart attack; coronary angiographic correlates of MRI microvascular obstruction [ Time Frame: Measured during participant's initial and follow-up MRIs ]

Secondary Outcome Measures :
  1. Relation of presence and extent of microvascular obstruction to clinical outcomes over 5 years [ Time Frame: Measured every 6 months for 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients listed on the cardiac catheterization schedule who are undergoing percutaneous coronary interventions.

Inclusion Criteria:

  • Undergoing diagnostic coronary angiography
  • Undergoing percutaneous coronary intervention

Exclusion Criteria:

  • Clinically unstable (i.e., demonstrates unstable cardiac rhythm or hemodynamics, supported on vasopressors or an intra-aortic balloon pump, and/or is actively ischemic) at the time of the MRI procedure
  • Unable to undergo MRI procedure (e.g., has non-MRI compatible implanted metallic objects, including cardiac pacemakers or cerebral aneurysm clips that are not MRI compatible)
  • Current glomerular filtration rate of less than 60mL/min/1.73m2
  • Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00692991

United States, Maryland
Johns Hopkins Medical Institution
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Kathy Wu, MD Johns Hopkins Medical Institution

Publications of Results:

Other Publications:

Responsible Party: Katherine C. Wu, Associate Professor of Medicine, Johns Hopkins University Identifier: NCT00692991     History of Changes
Other Study ID Numbers: 566
K23HL004444-01 ( U.S. NIH Grant/Contract )
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2013

Keywords provided by Katherine C. Wu, Johns Hopkins University:
Microvascular Obstruction
Cardiac MRI
Alcohol Ablation
Diagnostic PCI

Additional relevant MeSH terms:
Myocardial Infarction
Angina, Unstable
Cardiomyopathy, Hypertrophic
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathological Conditions, Anatomical
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases